Clinical trials: Bradycardia
Bradycardia, Heart Failure
BIO|CONCEPT.Amvia Study
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)…
- Trial name
- NCT05610176
- Testing
- Amvia Sky pacemaker or CRT-P device
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Bradycardia
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker
Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.
- Trial name
- NCT02030418
- Testing
- Leadless Pacemaker
- Where
- 59 sites in United States, Australia and 1 more
- Volunteers
- 952 people
- Sponsor
- Abbott Medical Devices
Bradycardia
ENHANCE-Efficacy of the Presence of Right Ventricular Apical Pacing Induced Ventricular Dyssynchrony as a Guiding Parameter for Biventricular Pacing in Patients With Bradycardia and Normal Ejection Fraction
The purpose of this clinical project is to evaluate the efficacy of the presence of Right Ventricular Apical (RVA) pacing induced ventricular dyssynchrony as a guiding parameter for bi-ventricular pacing in patients with…
- Trial name
- ENHANCE (NCT01559311)
- Testing
- CRT-P OFF, CRT-P ON, DDDR
- Where
- 7 sites in Australia, China and 3 more
- Volunteers
- 98 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Bradycardia
Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol
Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened regarding their baseline heart rate. If heart rate was > 75, patients were pretreated with 10mg bisoprolol (group 1) or 10mg bisoprolol…
- Trial name
- NCT02764970
- Testing
- Ivabradine 7.5mg orally
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Bradycardia
China Micra Transcatheter Pacing Study
The China Micra Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical trial utilizing Objective Performance Criterion (OPC) to confirm the safety and efficacy profile of the Micra system for…
- Trial name
- NCT03624504
- Testing
- Micra Transcatheter Pacing System (TPS)
- Where
- 7 sites in China
- Volunteers
- 82 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Complication Due to Immunization
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
- Trial name
- NCT02726178
- Testing
- Advil® Pediatric drops for infants
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Bradycardia, Arrhythmia
PREFER (Pacemaker Remote Follow-Up Evaluation and Review)
The purpose of the study is to compare remote pacemaker follow-up to current standard of care follow-up. The study will compare the rate of first diagnosis of clinically actionable events between patients who utilize the…
- Trial name
- NCT00294645
- Testing
- Transtelephonic monitoring (TTM), Medtronic CareLink® Network
- Where
- 45 sites in United States
- Volunteers
- 980 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Bradycardia
INGEVITY™ Observational Trial
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2.
- Trial name
- GENTLE (NCT02166606)
- Testing
- ImageReady MR Conditional Pacing System Implant
- Where
- 60 sites in Austria, Belgium and 11 more
- Volunteers
- 1,184 people
- Sponsor
- Boston Scientific Corporation
Pacemaker
BRADYCARE: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes
Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity.
- Trial name
- BRADYCARE (NCT01062126)
- Volunteers
- 3,389 people
- Sponsor
- Abbott Medical Devices
Sinus Bradycardia, Sinus Node Disease
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
- Conditions
- Sinus Bradycardia, Sinus Node Disease, Atrio-ventricular Block
- Trial name
- IES-ACap (NCT00832260)
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Bradyarrhythmia
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.
- Trial name
- OPTI-MIND (NCT00976482)
- Where
- Germany
- Volunteers
- 1,745 people
- Sponsor
- Boston Scientific Corporation
Bradycardia, Tachycardia
China 3T MRI Study
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans.
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Trial name
- NCT06038123
- Testing
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Where
- 5 sites in China
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
Bradycardia
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate…
- Trial name
- CLEAR (NCT00355797)
- Testing
- Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
- Where
- 99 sites in United States
- Volunteers
- 1,491 people
- Sponsor
- Biotronik, Inc.
Bradycardia
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and…
- Trial name
- TendrilMRI™ (NCT01528150)
- Volunteers
- 466 people
- Sponsor
- Abbott Medical Devices
Bradycardia
BlueSync Field Evaluation
The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of…
- Trial name
- NCT03518658
- Testing
- Evaluation Group, Control Group (Historical)
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 257 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Pacing
Model 4965 Post-Approval Study
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Trial name
- NCT01076348
- Where
- 107 sites in United States, Australia and 12 more
- Volunteers
- 73 people
- Sponsor
- Medtronic
Pregnancy
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
The purpose of this study is to determine what dose of medication administered through a combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of side effects.
- Trial name
- NCT02159807
- Testing
- Bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- St. Luke's-Roosevelt Hospital Center
Newborn Infants Having Asystole or Bradycardia at Birth
Chest Compression and Sustained Inflation
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns.
- Trial name
- NCT02083705
- Testing
- CC+SI, 3:1 CPR
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- University of Alberta